Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer (NCT03991819) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer
Canada40 participantsStarted 2019-09-20
Plain-language summary
This is a Phase I/Ib study whose purpose is to find out if combining an experimental drug called binimetinib with pembrolizumab is beneficial in people who have advanced non-small cell lung cancer. This study may also see if the combination is safe and may also find the best dose of binimetinib that should be added to pembrolizumab.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of non-small cell lung carcinoma with tumour PDL-1 TPS≥50% by 22C3 pharmDx immunohistochemistry. Patients must have EGFR wild-type, ALK-rearrangement negative metastatic or advanced NSCLC (stage IV or incurable stage III). Patients with neuroendocrine (carcinoid) carcinoma, small cell or mixed small cell and non-small cell carcinoma are not eligible.
* Must agree to use methods to prevent pregnancy as agreed upon between the investigator and the participant for at least 120 days after the last dose of study treatment.
* The participant provides written informed consent for the trial.
* Have measurable disease.
* Provide archival tumor tissue sample for KRAS/BRAF/STK11 mutation analysis or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Have a life expectancy of greater than 3 months.
* Be able to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* Have adequate organ function.
Exclusion Criteria:
* Female with positive urine pregnancy test.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, or a prior MEK inhibitor.
* Has received p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.